Document Number: OQ-ETFM-001
Version: 1.0
Effective Date: 2023-10-01
Review Date: 2024-10-01
Operational Qualification Protocol for Ointment Tube Filling Machine
Objective: To establish and document the operational qualification of the Ointment Tube Filling Machine to ensure it meets specified operational requirements for filling ophthalmic tubes.
Scope: This protocol applies to the Ointment Tube Filling Machine used in the Production/Packaging area for the filling of sterile ophthalmic products, including eye drops and ointments.
Responsibilities:
- Validation Team: Responsible for executing the OQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the OQ documentation.
- Production Staff: Responsible for operating the equipment during the OQ process.
Prerequisites:
- Installation Qualification (IQ) must be completed and approved.
- All personnel involved must be trained on the equipment operation.
- Equipment must be cleaned and sanitized per SOP.
Equipment Description: The Ointment Tube Filling Machine is designed for the sterile filling of ointments into ophthalmic tubes. It operates under controlled conditions to ensure product integrity and compliance with regulatory standards.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-001 | Verify fill weight accuracy | Fill weight within ±5% of target | Calibration records, weighing logs |
| OQ-002 | Check sealing integrity | No leaks detected under pressure test | Pressure test results |
| OQ-003 | Conduct reject audit trail verification | Audit trail shows no discrepancies | Audit trail report |
Detailed Test Cases:
Test Case OQ-001: Verify Fill Weight Accuracy
- Procedure: Fill a set number of tubes and weigh each tube.
- Expected Result: All filled tubes should have a fill weight within ±5% of the target.
- Data Integrity Check: Ensure all weights are recorded in the electronic batch record (EBR).
Test Case OQ-002: Check Sealing Integrity
- Procedure: Perform a pressure test on sealed tubes.
- Expected Result: No leaks should be detected.
- Data Integrity Check: Document pressure test results in the EBR.
Test Case OQ-003: Conduct Reject Audit Trail Verification
- Procedure: Review the audit trail for any reject entries.
- Expected Result: Audit trail shows no discrepancies.
- Data Integrity Check: Ensure audit trail data is securely stored and retrievable.
Deviations:
Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be developed if necessary.
Approvals:
Validated by: ____________________ Date: ____________
Approved by: ____________________ Date: ____________